Dr. Bakal is the Program Director for Provincial Research Data Services at Alberta Health Services, which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform. He also leads the Health Service Statistical and Analytics Methods teams. Over 10 years, he has worked with health services data, including randomized clinical trials. He completed his PhD jointly through the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen’s University. His work includes methodological contributions and analyses supporting international studies spanning business strategy, ophthalmology, cardiology, and geriatric medicine, as well as analyses of kinematic data, through peer-reviewed publications and conference presentations. Current interests include developing statistical methodology for time-to-event data and building classification tools to support patient decision-making processes. Dr. Abboud is a Board Certified Orthopaedic Surgeon and specializes in the treatment of patients with shoulder and elbow disorders. He is an internationally recognized authority on the treatment of shoulder and elbow disorders. He is a Professor of Orthopaedic Surgery at the Sidney Kimmel Medical College of Thomas Jefferson University and a core member of the teaching faculty for Rothman Orthopaedics. Dr. Abboud received his medical degree with honors from Georgetown University School of Medicine and went on to complete his residency in Orthopaedic surgery at the Hospital of the University of Pennsylvania where he served as the administrative chief resident and received the award. He subsequently completed two (one-year) fellowships at the University of Pennsylvania in Shoulder and Elbow surgery and Orthopaedic Biomechanics. Dr. Abboud has published over 250 peer reviewed publications, given over 600 invited lectures nationally and internationally, and published several textbooks and numerous book chapters. He has received the prestigious Neer award and Burkhardt award for excellence in research. Dr. Abboud performs a wide variety of simple and complex surgical procedures on the shoulder and elbow including arthroscopic surgery (e.g. rotator cuff repairs, instability surgery) comprehensive fracture care, as well as shoulder and elbow replacement (arthroplasty) procedures. Dr. Abboud is most proud of the fact that he has been caring for patients throughout the Philadelphia region and the Northeast region of the United States. Patients seek out his care from all regions of the United States and overseas. His goal is to always provide each patient with exceptional personalized care.Prof. J.J. Trey Crisco research interests are in musculoskeletal biomechanics where he focuses on upper extremity mechanics and osteoarthritis using advanced imaging analysis and on neuromuscular therapy. He also has an extensive interest in sports injury prevention and performance. His work has been primarily funded by the NIH and has resulted in over 200 peer-reviewed publications. He serves on several NIH study sections, editorial boards, and the scientific advisory committees of International Federation of Women's Lacrosse, US Lacrosse and USA Baseball. Prof. Crisco is a former Editor-in-Chief of the Journal of Applied Biomechanics and President of the American Society of Biomechanics. He has previously taught Basic Biomechanics and Product Design and Development, a joint effort between Industrial Design Department at RISD and Engineering at Brown University. He provides guest lectures and supports undergraduates for their independent studies and honors work, master's and doctoral students in his lab. Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.

• PrefaceAdam E. M. EltoraiIntroduction1. Introduction2. Translational Process3. Scientific Method4. Basic researchPRE-CLINCIAL5. Overview of Preclinical Research6. What Problem are you Solving?7. Types of Interventions8. Drug discovery9. Drug Testing10. Device discovery and prototyping11. Device testing12. Diagnostic Discovery13. Diagnostic Testing14. Other Product Types15. Procedural Technique Development16. Behavioral InterventionCLINICAL: FUNDAMENTALS17. Introduction to clinical research18. The question19. Study population20. Outcome measurements21. Optimizing the questionSTATISTICAL PRINCIPLES22. Common issues in analysis23. Basic statistical principles24. Distributions25. Hypotheses and error types26. Power27. Regression28. Continuous variable analyses29. Categorical variable analyses30. Analysis of variance31. Correlation32. Biases33. Basic science statisticsCLINICAL: STUDY TYPES34. Design principles35. Case series36. Case-control study37. Cohort study38. Cross-section study39. Longitudinal Study40. Clinical trials41. Meta-analysis42. Cost effectiveness study43. Diagnostic test evaluation44. Reliability study45. Database studies46. Surveys and questionnaires47. Qualitative methods and mixed methodsCLINICAL TRIALS48. Randomized control49. Nonrandomized control50. Historical control51. Cross-over52. Withdrawal studies53. Factorial design54. Group allocation55. Hybrid design56. Large, pragmatic57. Adaptive58. Randomization59. Blinding60. Multicenter considerations61. Registries62. Phases of Clinical Trials63. IDEAL Framework64. Artificial Intelligence65. Patient PerspectivesCLINICAL: PREPARATION66. Sample size67. Budgeting 68. Ethics and review boards69. Regulatory considerations for new drugs and devices70. Funding approaches71. Subject recruitment72. Data management74. Statistical Software75. Report forms76. Subject adherence77. Survival analysis78. Monitoring committee in clinical trialsREGULATORY BASICS79. FDA Overview80. IND81. New drug application82. Devices83. Radiation-emitting Electronic Products84. Orphan Drugs85. Biologics86. Combination Productions87. Foods88. Cosmetics89. CMC and GxP90. Non-US regulatory91. Post-market drug safety monitoring92. Post-market device safety monitoringCLINICAL IMPLEMENTATION93. Implementation Research94. Design and Analysis95. Mixed Methods Research96. Population- and setting-specific implementationPUBLIC HEALTH97. Public Health98. Epidemiology99. Factors100. Good questions101. Population- and environmental-specific considerations102. Law, policy, and ethics103. Healthcare institutions and systems104. Public health institutions and systemsPractical Resources105. Presenting data106. Manuscript preparation107. Building a team108. Patent basics109. Venture pathways110. SBIR/STTR111. Sample forms and templates

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Dr. Bakal is the Program Director for Provincial Research Data Services at Alberta Health Services, which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform. He also leads the Health Service Statistical and Analytics Methods teams. Over 10 years, he has worked with health services data, including randomized clinical trials. He completed his PhD jointly through the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen’s University. His work includes methodological contributions and analyses supporting international studies spanning business strategy, ophthalmology, cardiology, and geriatric medicine, as well as analyses of kinematic data, through peer-reviewed publications and conference presentations. Current interests include developing statistical methodology for time-to-event data and building classification tools to support patient decision-making processes. Dr. Abboud is a Board Certified Orthopaedic Surgeon and specializes in the treatment of patients with shoulder and elbow disorders. He is an internationally recognized authority on the treatment of shoulder and elbow disorders. He is a Professor of Orthopaedic Surgery at the Sidney Kimmel Medical College of Thomas Jefferson University and a core member of the teaching faculty for Rothman Orthopaedics. Dr. Abboud received his medical degree with honors from Georgetown University School of Medicine and went on to complete his residency in Orthopaedic surgery at the Hospital of the University of Pennsylvania where he served as the administrative chief resident and received the award. He subsequently completed two (one-year) fellowships at the University of Pennsylvania in Shoulder and Elbow surgery and Orthopaedic Biomechanics. Dr. Abboud has published over 250 peer reviewed publications, given over 600 invited lectures nationally and internationally, and published several textbooks and numerous book chapters. He has received the prestigious Neer award and Burkhardt award for excellence in research. Dr. Abboud performs a wide variety of simple and complex surgical procedures on the shoulder and elbow including arthroscopic surgery (e.g. rotator cuff repairs, instability surgery) comprehensive fracture care, as well as shoulder and elbow replacement (arthroplasty) procedures. Dr. Abboud is most proud of the fact that he has been caring for patients throughout the Philadelphia region and the Northeast region of the United States. Patients seek out his care from all regions of the United States and overseas. His goal is to always provide each patient with exceptional personalized care.Prof. J.J. Trey Crisco research interests are in musculoskeletal biomechanics where he focuses on upper extremity mechanics and osteoarthritis using advanced imaging analysis and on neuromuscular therapy. He also has an extensive interest in sports injury prevention and performance. His work has been primarily funded by the NIH and has resulted in over 200 peer-reviewed publications. He serves on several NIH study sections, editorial boards, and the scientific advisory committees of International Federation of Women's Lacrosse, US Lacrosse and USA Baseball. Prof. Crisco is a former Editor-in-Chief of the Journal of Applied Biomechanics and President of the American Society of Biomechanics. He has previously taught Basic Biomechanics and Product Design and Development, a joint effort between Industrial Design Department at RISD and Engineering at Brown University. He provides guest lectures and supports undergraduates for their independent studies and honors work, master's and doctoral students in his lab. Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.

• PrefaceAdam E. M. EltoraiIntroduction1. Introduction2. Translational Process3. Scientific Method4. Basic researchPRE-CLINCIAL5. Overview of Preclinical Research6. What Problem are you Solving?7. Types of Interventions8. Drug discovery9. Drug Testing10. Device discovery and prototyping11. Device testing12. Diagnostic Discovery13. Diagnostic Testing14. Other Product Types15. Procedural Technique Development16. Behavioral InterventionCLINICAL: FUNDAMENTALS17. Introduction to clinical research18. The question19. Study population20. Outcome measurements21. Optimizing the questionSTATISTICAL PRINCIPLES22. Common issues in analysis23. Basic statistical principles24. Distributions25. Hypotheses and error types26. Power27. Regression28. Continuous variable analyses29. Categorical variable analyses30. Analysis of variance31. Correlation32. Biases33. Basic science statisticsCLINICAL: STUDY TYPES34. Design principles35. Case series36. Case-control study37. Cohort study38. Cross-section study39. Longitudinal Study40. Clinical trials41. Meta-analysis42. Cost effectiveness study43. Diagnostic test evaluation44. Reliability study45. Database studies46. Surveys and questionnaires47. Qualitative methods and mixed methodsCLINICAL TRIALS48. Randomized control49. Nonrandomized control50. Historical control51. Cross-over52. Withdrawal studies53. Factorial design54. Group allocation55. Hybrid design56. Large, pragmatic57. Adaptive58. Randomization59. Blinding60. Multicenter considerations61. Registries62. Phases of Clinical Trials63. IDEAL Framework64. Artificial Intelligence65. Patient PerspectivesCLINICAL: PREPARATION66. Sample size67. Budgeting 68. Ethics and review boards69. Regulatory considerations for new drugs and devices70. Funding approaches71. Subject recruitment72. Data management74. Statistical Software75. Report forms76. Subject adherence77. Survival analysis78. Monitoring committee in clinical trialsREGULATORY BASICS79. FDA Overview80. IND81. New drug application82. Devices83. Radiation-emitting Electronic Products84. Orphan Drugs85. Biologics86. Combination Productions87. Foods88. Cosmetics89. CMC and GxP90. Non-US regulatory91. Post-market drug safety monitoring92. Post-market device safety monitoringCLINICAL IMPLEMENTATION93. Implementation Research94. Design and Analysis95. Mixed Methods Research96. Population- and setting-specific implementationPUBLIC HEALTH97. Public Health98. Epidemiology99. Factors100. Good questions101. Population- and environmental-specific considerations102. Law, policy, and ethics103. Healthcare institutions and systems104. Public health institutions and systemsPractical Resources105. Presenting data106. Manuscript preparation107. Building a team108. Patent basics109. Venture pathways110. SBIR/STTR111. Sample forms and templates

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Dr. Bakal is the Program Director for Provincial Research Data Services at Alberta Health Services, which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform. He also leads the Health Service Statistical and Analytics Methods teams. Over 10 years, he has worked with health services data, including randomized clinical trials. He completed his PhD jointly through the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen’s University. His work includes methodological contributions and analyses supporting international studies spanning business strategy, ophthalmology, cardiology, and geriatric medicine, as well as analyses of kinematic data, through peer-reviewed publications and conference presentations. Current interests include developing statistical methodology for time-to-event data and building classification tools to support patient decision-making processes. Dr. Abboud is a Board Certified Orthopaedic Surgeon and specializes in the treatment of patients with shoulder and elbow disorders. He is an internationally recognized authority on the treatment of shoulder and elbow disorders. He is a Professor of Orthopaedic Surgery at the Sidney Kimmel Medical College of Thomas Jefferson University and a core member of the teaching faculty for Rothman Orthopaedics. Dr. Abboud received his medical degree with honors from Georgetown University School of Medicine and went on to complete his residency in Orthopaedic surgery at the Hospital of the University of Pennsylvania where he served as the administrative chief resident and received the award. He subsequently completed two (one-year) fellowships at the University of Pennsylvania in Shoulder and Elbow surgery and Orthopaedic Biomechanics. Dr. Abboud has published over 250 peer reviewed publications, given over 600 invited lectures nationally and internationally, and published several textbooks and numerous book chapters. He has received the prestigious Neer award and Burkhardt award for excellence in research. Dr. Abboud performs a wide variety of simple and complex surgical procedures on the shoulder and elbow including arthroscopic surgery (e.g. rotator cuff repairs, instability surgery) comprehensive fracture care, as well as shoulder and elbow replacement (arthroplasty) procedures. Dr. Abboud is most proud of the fact that he has been caring for patients throughout the Philadelphia region and the Northeast region of the United States. Patients seek out his care from all regions of the United States and overseas. His goal is to always provide each patient with exceptional personalized care.Prof. J.J. Trey Crisco research interests are in musculoskeletal biomechanics where he focuses on upper extremity mechanics and osteoarthritis using advanced imaging analysis and on neuromuscular therapy. He also has an extensive interest in sports injury prevention and performance. His work has been primarily funded by the NIH and has resulted in over 200 peer-reviewed publications. He serves on several NIH study sections, editorial boards, and the scientific advisory committees of International Federation of Women's Lacrosse, US Lacrosse and USA Baseball. Prof. Crisco is a former Editor-in-Chief of the Journal of Applied Biomechanics and President of the American Society of Biomechanics. He has previously taught Basic Biomechanics and Product Design and Development, a joint effort between Industrial Design Department at RISD and Engineering at Brown University. He provides guest lectures and supports undergraduates for their independent studies and honors work, master's and doctoral students in his lab. Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.

• PrefaceAdam E. M. EltoraiIntroduction1. Introduction2. Translational Process3. Scientific Method4. Basic researchPRE-CLINCIAL5. Overview of Preclinical Research6. What Problem are you Solving?7. Types of Interventions8. Drug discovery9. Drug Testing10. Device discovery and prototyping11. Device testing12. Diagnostic Discovery13. Diagnostic Testing14. Other Product Types15. Procedural Technique Development16. Behavioral InterventionCLINICAL: FUNDAMENTALS17. Introduction to clinical research18. The question19. Study population20. Outcome measurements21. Optimizing the questionSTATISTICAL PRINCIPLES22. Common issues in analysis23. Basic statistical principles24. Distributions25. Hypotheses and error types26. Power27. Regression28. Continuous variable analyses29. Categorical variable analyses30. Analysis of variance31. Correlation32. Biases33. Basic science statisticsCLINICAL: STUDY TYPES34. Design principles35. Case series36. Case-control study37. Cohort study38. Cross-section study39. Longitudinal Study40. Clinical trials41. Meta-analysis42. Cost effectiveness study43. Diagnostic test evaluation44. Reliability study45. Database studies46. Surveys and questionnaires47. Qualitative methods and mixed methodsCLINICAL TRIALS48. Randomized control49. Nonrandomized control50. Historical control51. Cross-over52. Withdrawal studies53. Factorial design54. Group allocation55. Hybrid design56. Large, pragmatic57. Adaptive58. Randomization59. Blinding60. Multicenter considerations61. Registries62. Phases of Clinical Trials63. IDEAL Framework64. Artificial Intelligence65. Patient PerspectivesCLINICAL: PREPARATION66. Sample size67. Budgeting 68. Ethics and review boards69. Regulatory considerations for new drugs and devices70. Funding approaches71. Subject recruitment72. Data management74. Statistical Software75. Report forms76. Subject adherence77. Survival analysis78. Monitoring committee in clinical trialsREGULATORY BASICS79. FDA Overview80. IND81. New drug application82. Devices83. Radiation-emitting Electronic Products84. Orphan Drugs85. Biologics86. Combination Productions87. Foods88. Cosmetics89. CMC and GxP90. Non-US regulatory91. Post-market drug safety monitoring92. Post-market device safety monitoringCLINICAL IMPLEMENTATION93. Implementation Research94. Design and Analysis95. Mixed Methods Research96. Population- and setting-specific implementationPUBLIC HEALTH97. Public Health98. Epidemiology99. Factors100. Good questions101. Population- and environmental-specific considerations102. Law, policy, and ethics103. Healthcare institutions and systems104. Public health institutions and systemsPractical Resources105. Presenting data106. Manuscript preparation107. Building a team108. Patent basics109. Venture pathways110. SBIR/STTR111. Sample forms and templates

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